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Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Key facts

Who runs it
Istituto Ortopedico Rizzoli
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
204 people, planned
Started
16 Feb 2022
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Collagen
  • Placebo (saline solution)
Record updated
3 February 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Unilateral involvement
  • Signs and symptoms of degenerative pathology of knee cartilage
  • Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades)
  • Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment)
  • Ability and consent of patients to actively participate in clinical follow-up

Who cannot take part

  • Patients who have undergone intra-articular injections of another substance in the previous 6 months
  • Patients undergoing knee surgery within the previous 12 months
  • Patients on anticoagulant therapy
  • Patients abusing alcoholic beverages, drugs or medications
  • Patients with malignant neoplasms
  • Patients with rheumatic diseases
  • Patients with diabetes
  • Patients with hematologic diseases (coagulopathies)
  • Patients with metabolic disorders of the thyroid gland
  • Patients with established hypersensitivity to bovine collagen or vitamin C
  • Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area
  • Body Mass Index > 35
  • Pregnant or lactating women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single intra-articular collagen injection versus a single placebo (saline solution) infiltration in the infiltrative treatment of knee osteoarthritis. The evaluation will be performed through clinical, subjective and objective assessments.

The 2 groups in the trial

  • Collagen InjectionTreatment being tested

    This group of patients will be treated with single intra-articular injection of collagen.

    Treatment: Collagen

  • Placebo (saline solution)Placebo, for comparison

    This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
Fit questions
Built from NCT04998188, who can take part
Record updated
3 February 2026